No registrations found.
ID
Source
Brief title
Health condition
Crohn's disease; Perianal fistula
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical closure combined with radiographic closure of the fistula tract after surgical intervention at 6 months. Clinical closure of fistula tract is defined as closure of the external openings at physical examination. Radiographic closure is defined as the amount of percent decrease in luminal activity measured by hyper intensity on pelvic T2-weighted MRI.
Secondary outcome
• Surgical data
• Length of stay in the hospital
• Postoperative complications (infection / bleeding) of the perianal and liposuction sites
• Time to clinical healing. Clinical healing will be defined as closure of the internal and external opening at physical examination
• Need of re-intervention and/or readmissions within 6 months follow up (depending on available time to follow-up)
Background summary
This study aims to assess the efficacy of additional injection of Platelet-Rich Stroma in the surgical treatment of Crohn’s perianal fistulas. A prospective case series will be set up that will include patients with Crohn’s fistulas who undergo PRS treatment during fistula surgery. The primary outcome is defined as combined clinical and radiographic closure healing on postoperative MRI. Follow-up MRI will be performed after clinical closure of the fistula tract, preferably within 6 months postoperatively.
This study was already submitted in January 2019 by the researcher. However, due to the transition to the new website of the NTR the study is registered in 2020.
Study objective
Addition of Platelet Rich Stroma in the surgical treatment of Crohn’s perianal fistulas improves radiographic healing.
Study design
Follow-up until 12 months posteratively
Inclusion criteria
Patients with Crohn’s perianal fistulas, defined as one or more perianal fistula tracts in patients with previously endoscopic or histologic confirmed Crohn’s disease.
Exclusion criteria
• Presence of pelvic sepsis or abscesses at the time of study entry.
• Perianal fistula is a rectovaginal fistula.
• Any oncological event in the patients history in the previous five years.
• Any other medical condition that in the judgement of the investigator could interfere with their optimal participation in the study or produce a significant risk to the patient.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8417 |
| Other | METC Erasmus MC : MEC-2019-0425 |